Qualio
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
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SiteDocs
Your Safety & Compliance Made Simple! Businesses that operate in the construction, oil & gas, mining, manufacturing, electrical, plumbing, heating, and excavating industries know all too well how important it is to comply with all mandatory documentation. It is also important to know how a company organizes everything.
SiteDocs is an interactive safety management system that transforms organizations from pen-and paper archiving to a fully cloud-based, digital workspace. The system is accessible from any device running iOS or Android and features allow users to work remotely, on mobile, or offline. Employees can now sign and upload photos, add comments, and acknowledge receipt of important documentation. Administrators can also ensure that records, reports and certifications of staff are automatically updated by using the web-based panel's system parameters.
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QT9 QMS
Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals.
QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations.
Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included.
Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com
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Product Comply
Product Comply provides extensive 360-degree oversight of changing regulations and standards that affect your products, whether they belong to the categories of medical devices, electronics, furniture, cosmetics, or others. Our software is tailored to meet the specific compliance requirements of any regulatory environment. It adeptly manages all worldwide regulations pertaining to crucial areas like health, safety, and environmental concerns. Each regulation is systematically aligned with your product portfolio, considering components, materials, and chemicals, ensuring you remain proactive regarding any shifts in the regulatory landscape that could influence your operations. As global EHS (Environment, Health & Safety) regulations and compliance frameworks continually evolve, leveraging sophisticated software that tracks these changes is essential for minimizing monitoring workloads, thus allowing your team to concentrate on strategic initiatives that safeguard your business. This not only enhances compliance but also fosters innovation and growth by freeing up resources for more critical business strategies.
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